GlaxoSmithKline/HGS lupus drug Benlysta cleared by US FDA

After an agency delay following an advisory panel backing last November, the US Food and Drug Administration yesterday finally approved UK pharma giant GlaxoSmithKline (LSE: GSK) and co-marketing partner Human Genome Sciences’ (Nasdaq: HGSI) Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus).

The US label includes the following limitations of use: The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of belimumab is therefore not recommended in these situations.

Thomas Watkins, president and chief executive of HGS, stated last evening: “We expect to have this novel therapy available to physicians and patients within about two weeks, and our entire organization looks forward to the positive impact we hope this new therapy will have for patients with systemic lupus.”